Background: reporting of child-centric systematic reviews (SRs) (i.e. SRs including children), differs from adult SRs in several key aspects, such as descriptions of child-tailored interventions, justifiable comparators, valid outcomes and outcome measures, and separate synthesis for targeted pediatric age subgroups. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses – Protocol (PRISMA-P 2015) statement and its corresponding statement for reports (PRISMA 2009) does not cover complexities associated with reporting SR in the pediatric population.
Objectives: to develop PRISMA-P-C (Protocol for Children) and PRISMA-C (Report for Children) statements as extensions to the PRISMA-P and PRISMA statements, respectively, tailored to the specific requirements of reporting protocols and reports of SRs and meta-analyses (MA) that include newborns, children and adolescents, or mixed child and adult populations.
Methods: we developed this reporting guidance using the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) framework for health research reporting guidelines by conducting:
1) a scoping review identified potential child-centric items;
2) a SR of child-centric SR protocols and reports published in MEDLINE and Embase between 2010 and 2014, which evaluated the clarity and transparency in reporting of child-centric modification and extension items and identified areas where reporting could be strengthened;
3) a web-based Delphi survey of researchers with experience in child-centric SRs that contributed input on the inclusion and exclusion of potential reporting items;
4) an international face-to-face consensus meeting of researchers, clinicians, and methodologists experienced in conducting child-centric SRs and MA, and journal editors.
Results: the final PRISMA-P-C checklist features three new extension items to PRISMA-P for reporting child-centric SR and MA protocols: two items focus on rationale for a review in children and specification of eligibility criteria, respectively, and request explicit justifications for intervention, comparator and outcome for targeted pediatric age group, and a separate data synthesis for adult and targeted pediatric age groups in 'mixed' reviews. Wording of four PRISMA-P items has been modified to specify review methods in targeted pediatric age subgroups. We have added seven extension items to the PRISMA-C checklist. These include a description of subgroup analyses for the targeted pediatric age group(s), justifications for intervention, comparator and outcome for these age group(s), justification for combining adult and pediatric data, if done, and appropriateness of outcome measures (i.e. validity, feasibility, reliability and responsiveness) for the targeted pediatric age group(s). We modified wording for 11 PRISMA items.
Conclusions: PRISMA-P-C and PRISMA-C provide guidelines for reporting protocols and reports of SRs and MA in newborns, children and adolescents including mixed adult and child reviews.
Patient or healthcare consumer involvement: none